Actively Recruiting

Age: 18Years +
All Genders
ID04630535

Obstructive Sleep Apnea as Remote Ischemic Preconditioning in Patients Scheduled for Aorto-bifemoral Bypass Surgery

Led by St. Anne's University Hospital Brno, Czech Republic · Updated on 2026-04-27

100

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

S

St. Anne's University Hospital Brno, Czech Republic

Lead Sponsor

M

Masaryk University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the impact of obstructive sleep apnea (OSA) as a possible protective factor against ischemia and reperfusion (I/R) injury during elective abdominal aortic aneurysm (AAA) repair and aorto-bifemoral bypass surgery. The study investigates whether patients with OSA experience less I/R injury and fewer postoperative complications compared to those without OSA. The relationship between OSA severity and I/R injury is also examined to understand if greater OSA severity corresponds to reduced injury. Participants scheduled for elective aorto-bifemoral bypass surgery, including those with AAA and Leriche syndrome, will be observed. Polygraphy sleep studies using the Embletta system will be conducted two nights before surgery, alongside STOP-BANG and Epworth questionnaires to assess OSA. Patients are grouped based on OSA status (presence or absence) and undergo the standard surgical procedure without additional interventions. During the study, markers of I/R injury will be measured at multiple time points: before anesthesia, and at 3, 12, 24 hours, and on the fifth postoperative day after aorta de-clamping. Cardiovascular and pulmonary complications will be monitored for 30 days after surgery. These assessments aim to track the extent of I/R injury and related complications to better understand the protective role of OSA in vascular surgery. The total study period extends to 30 days post-operation with detailed outcome evaluations.

CONDITIONS

Brief Title

OSA as a Remote Ischemic Preconditioning in Vascular Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for elective aorto-bifemoral bypass surgery, including those with abdominal aortic aneurysm and Leriche syndrome
Not Eligible

You will not qualify if you...

  • Emergency or emergent surgery
  • Aorto-bifemoral bypass using deep vein graft
  • Re-operations
  • Known obstructive sleep apnea with CPAP treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 2 nights before surgery

Participants undergo polygraphy measurements and complete questionnaires for assessment of sleep apnea before surgery.

1 baseline visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and the first 5 post-operative days

Participants undergo elective aorto-bifemoral bypass surgery followed by immediate post-operative assessments.

Multiple assessments on surgery day and 5 post-operative days

Post-operative Follow-up

Duration - Up to 30 days post-surgery

Participants are monitored for cardiovascular and pulmonary complications for up to 30 days after surgery.

Follow-up visits as needed during 30 days

Trial Site Locations

Total: 1 location

1

St. Anne's University Hospital Brno

Brno, Czech Republic, Czechia, 65691

Actively Recruiting

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Research Team

I

Ivan Cundrle, M.D., Ph.D.

M

Marek Lukes, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Frequently Asked Questions

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Remote ischemic preconditioning for renal and cardiac protection during endovascular aneurysm repair: a randomized controlled trial.

Stewart R Walsh, Jonathan R Boyle, Tjun Y Tang...

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Remote ischemic preconditioning for renal protection during elective open infrarenal abdominal aortic aneurysm repair: randomized controlled trial.

Stewart R Walsh, Umar Sadat, Jonathan R Boyle...

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Limb remote ischemic preconditioning for intestinal and pulmonary protection during elective open infrarenal abdominal aortic aneurysm repair: a randomized controlled trial.

Cai Li, Yun-Sheng Li, Miao Xu...

https://pubmed.ncbi.nlm.nih.gov/23353795

Remote ischemic preconditioning does not affect the incidence of acute kidney injury after elective abdominal aortic aneurysm repair.

Noelle Murphy, Ajith Vijayan, Stephen Frohlich...

https://pubmed.ncbi.nlm.nih.gov/25281045

Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES): A Prospective, Randomized, Sham-Controlled Phase II Clinical Trial.

Santiago Garcia, Thomas S Rector, Marina Zakharova...

https://pubmed.ncbi.nlm.nih.gov/27688236

Repeated Episodes of Remote Ischemic Preconditioning for the Prevention of Myocardial Injury in Vascular Surgery.

Kate N Thomas, James D Cotter, Michael J A Williams...

https://pubmed.ncbi.nlm.nih.gov/27075990

Remote ischaemic preconditioning versus sham procedure for abdominal aortic aneurysm repair: an external feasibility randomized controlled trial.

Ronelle Mouton, Jon Pollock, Jasmeet Soar...

https://pubmed.ncbi.nlm.nih.gov/26303818